Aortic Valve StenosisNCT00986193
Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
A study testing Transapical Aortic Valve Implantation and Conventional Aortic Valve Surgery in people with Aortic Valve Stenosis, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Transapical Aortic Valve Implantation and Conventional Aortic Valve Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2008to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Significant aortic valve stenosis (valve area < 1cm2)
- Age > 75 (years Aarhus University Hospital, Skejby)
- Age > 80 years (other participating centres)
- Operable by conventional surgery AND transapical stent valve implantation
- Expected survival > 1 year following successful treatment
- Accept of participation and in follow-up investigations after adequate information
- Informed consent
Who cannot join
- Coronary artery disease requiring PCI or CABG
- Earlier cardiac surgery
- Myocardial infarction within 24 hours
- Kidney failure requiring any dialysis
- Ongoing infection
- Acute surgery
- Allergy to ASA or Clopidogrel
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Skejby
Aarhus N, Central Jutland, 8200
About this study
Official title: Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.
Read the detailed description
The purpose of the study is to compare the new established apical stent valve treatment with conventional surgical intervention using biological valve prostheses in patients with severe aortic valve stenosis.
The Edwards-SAPIENTM Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA) will be used in the stent valve group. The Carpentier-Edwards-Perimount Heart Valve (Edwards Lifesciences, Irvine, CA) will be recommended for the conventional surgery group.(Edwards Lifesciences, Irvine, CA).
Heart centres in the Nordic region with experience (>10 cases) in apical stent valve treatment and in conventional surgical treatment of high risk patients with aortic valve stenosis. The study will be initiated at Aarhus University Hospital, Skejby, Denmark.
Study hypothesis:
As compared to conventional aortic valve substitution in patients aged >75 years, apical stent valve treatment reduces the rates of death, cerebrovascular insult (CVI) and need of dialysis for renal failure 1 month after the treatment.
Primary clinical end-point:
Combined end-point consisting of death, CVI and/or renal failure with need for haemodialysis, 1 month after index treatment.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Transapical Aortic Valve Implantation, Conventional Aortic Valve Surgery
- Keywords
- Aortic Valve Stenosis, Stent Valve, Biological Aortic Valve Prosthesis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transapical Aortic Valve ImplantationProcedure or surgery
Insertion of a stent valve using catheter-based technique through a mini thoracotomy
Conventional Aortic Valve SurgeryProcedure or surgery
Operation using heart-lung machine, with insertion of a biological artificial heart valve
| Study group | Role | What they receive |
|---|---|---|
| Conventional Aortic Valve Surgery | Active comparator | Insertion of a biological valve Receives: Procedure: Conventional Aortic Valve Surgery |
| Transapical Aortic Valve Implantation | Experimental | Transapical implantation of an Edwards SAPIENtm valve Receives: Procedure: Transapical Aortic Valve Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death, CVI and/or renal failure requiring any dialysis
Measured: 1 month
Secondary outcomes (1)
Echocardiographic results, valve performance
Measured: 1 month with subseguent followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2011
- Study completionApr 2016
Why it stopped: By recommendation from the Data and safety monitoring board
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Danish Heart Foundation
- Responsible party
- Principal investigator, Evald Hoej Christiansen, Aarhus University Hospital Skejby
- Investigators
- Evald H Christiansen, MD, Principal investigator, Skejby Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986193
- Sponsor's protocol ID
- Skejby 2008-1
- Status last verified
- May 2017
- First submitted
- 25 Sep 2009
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT00986193
- Acronym / sponsor ID
- Skejby 2008-1
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic Valve Stenosis, Stent Valve, Biological Aortic Valve Prosthesis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: By recommendation from the Data and safety monitoring board
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Odense University Hospital, Danish Heart Foundation
- Study start
- Dec 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.
Detailed description
The purpose of the study is to compare the new established apical stent valve treatment with conventional surgical intervention using biological valve prostheses in patients with severe aortic valve stenosis.
The Edwards-SAPIENTM Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA) will be used in the stent valve group. The Carpentier-Edwards-Perimount Heart Valve (Edwards Lifesciences, Irvine, CA) will be recommended for the conventional surgery group.(Edwards Lifesciences, Irvine, CA).
Heart centres in the Nordic region with experience (>10 cases) in apical stent valve treatment and in conventional surgical treatment of high risk patients with aortic valve stenosis. The study will be initiated at Aarhus University Hospital, Skejby, Denmark.
Study hypothesis:
As compared to conventional aortic valve substitution in patients aged >75 years, apical stent valve treatment reduces the rates of death, cerebrovascular insult (CVI) and need of dialysis for renal failure 1 month after the treatment.
Primary clinical end-point:
Combined end-point consisting of death, CVI and/or renal failure with need for haemodialysis, 1 month after index treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Aortic Valve Surgery | Active comparator | Procedure: Conventional Aortic Valve SurgeryInsertion of a biological valve |
| Transapical Aortic Valve Implantation | Experimental | Procedure: Transapical Aortic Valve ImplantationTransapical implantation of an Edwards SAPIENtm valve |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Significant aortic valve stenosis (valve area < 1cm2)
- Age > 75 (years Aarhus University Hospital, Skejby)
- Age > 80 years (other participating centres)
- Operable by conventional surgery AND transapical stent valve implantation
- Expected survival > 1 year following successful treatment
Key exclusion criteria (7 listed)
- Coronary artery disease requiring PCI or CABG
- Earlier cardiac surgery
- Myocardial infarction within 24 hours
- Kidney failure requiring any dialysis
- Ongoing infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transapical Aortic Valve ImplantationInsertion of a stent valve using catheter-based technique through a mini thoracotomy | Procedure or surgery | Transapical Aortic Valve Implantation |
| Conventional Aortic Valve SurgeryOperation using heart-lung machine, with insertion of a biological artificial heart valve | Procedure or surgery | Conventional Aortic Valve Surgery |
Primary outcome
Death, CVI and/or renal failure requiring any dialysis
Time frame: 1 month
1 secondary outcome
Echocardiographic results, valve performance
Time frame: 1 month with subseguent followup
Results and safety
The study was stopped early (reason given: By recommendation from the Data and safety monitoring board). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evald H Christiansen, MD principal investigator
Skejby Hospital, Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transapical Aortic Valve Implantation and Conventional Aortic Valve Surgery in people with Aortic Valve Stenosis, run by Aarhus University Hospital Skejby at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: By recommendation from the Data and safety monitoring board). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death, CVI and/or renal failure requiring any dialysis (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.